Senior Associate, Clinical Research

Job Title: Senior Associate, Clinical Research  

Role Level: Individual Contributor (IC)

Supervisor/Manager Title: Director, Clinical Affairs 

Job Location & Environment: Irvine, CA, Corporate Office

Job Description Summary: The Senior Clinical Research Associate will report to the Director, Clinical Affairs, and will play a key role in proactively supporting the conduct of pre-market clinical studies and ensure compliance with all regulatory requirements. The ideal candidate will have a thorough knowledge of Good Clinical Practices (GCP) and applicable regulations. 

Job Responsibilities: 

• Support site management and interact with site coordinators, investigators, and field monitors in collecting data and resolving queries to meet the protocol requirements in a timely manner.
• Ensure quality data management activities – i.e., data review, query generation and resolution. Generate status reports to clinical staff and management.
• Generate queries to resolve data issues and apply corrections to database.
• Act as a point person for all data related to clinical group, and to provide data to cross-functional departments.
• Conduct EDC training to external teams and sites.
• Maintain Trial Master Files and trackers for clinical trials.
• Manage trial-related regulatory documents and provide follow-up action listings to ensure that all clinical documentation required by regulations and JenaValve procedures is current.
• Conduct periodic audits of internal files to ensure compliance per site Institutional Review Board (IRB) and/or Ethics Committee (EC) policy (i.e. IRB continuing review approval period and expiration dates). 
• Provide clinical operational support during preparation for and conduct of all clinical audits and inspections.
• Contribute to the development and implementation of departmental policies, standards, and process improvement initiatives. 
• Partner with management to manage external vendors, including ongoing supplier qualification.
• Assist field clinical monitors in preparation for site training and monitoring visits
• Support co-monitoring of local sites on an as-needed basis.

Required Education and Experience: 

• 2+ year of experience in clinical trial research is required (preferred in medical devices).
• Advanced degree in a biological science / pharmacy/ nursing desired.

Skills and Abilities Required for This Job: 

• Proficient in clinical trial management and electronic data capture systems to document and record information.
• Excellent communication skills (written and verbal English) so as to be able to build effective relationships with trial center staff and colleagues.
• Deep knowledge of GCPs governing the conduct of clinical trials; working knowledge of Medical Device Directive 93/42/EEC, ISO14155 and ICH guidelines. 
• Very organized and able to pay close attention to detail.
• Team player with a willingness to help where needed and work with diverse people.

Physical Requirements: 

• Ability to travel up to 20% time.